Devices And Methods For Treating Conditions Caused By Affarent Nerve Signals

ABSTRACT

Devices and methods for treating conditions, such as overactive bladder, caused by afferent nerve signals involving the creation of dissection planes that interrupt the afferent nerve signals.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/935,753 filed Feb. 4, 2014, entitled Devices And Methods ForTreating Conditions Caused By Affarent Nerve Signals, which is herebyincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The modified Inglemann-Sundberg (IS) procedure created a submucosaldissection plane in the trigone region of the bladder, for purposes ofinterrupting the afferent nerves emanating from the bladder trigone, asa treatment for OAB (Over active bladder). This dissection plane wascreated with basic surgical technique, via the superior portion of thevagina. A flap was created then re-approximated to result in adissection layer within the congruent tissue of the vagina and trigoneof the bladder. While apparently successful clinically, few physicianshave adopted this. Even early study authors apparently do not continueto perform this procedure.

Some limiting factors in adoption of this procedure is its relativeinvasiveness, use of rudimentary surgical tools, together with thechallenge of creating the dissection plane essentially blindly, withoutclear visual bladder landmarks from the vaginal approach.

OBJECTS AND SUMMARY OF THE INVENTION

Disclosed here are several concepts that mainly emulate the clinicalresult of the modified IS procedure, but do so in a way that would bemore precise, less invasive, and/or easier to perform, as well as otherpotential advantages.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is a diagram depicting the female urogenital anatomy;

FIG. 2 is a diagram of a female bladder;

FIG. 3 is a diagram depicting the location of the trigone region of afemale bladder in relation to the rest of the female urogenital anatomy;

FIG. 4 is a diagram of an embodiment of a device of the invention beinginserted into a female urogenital region;

FIG. 5 is a diagram of a dissection layer formed by an embodiment of amethod of the invention;

FIG. 6 is a diagram of multiple dissection layers formed by anembodiment of a method of the invention;

FIG. 7 is an elevation of an embodiment of a visualization scope of theinvention;

FIG. 8 is a section of the embodiment of FIG. 7 taken along sectionlines A-A;

FIGS. 9-10 are elevations of an embodiment of a catheter of theinvention;

FIG. 11 is a diagram of an embodiment of a visualization scope of theinvention being used in an embodiment of a method of the invention;

FIG. 12 is a diagram of an embodiment of a guidewire of the inventionplaced in a female urogenital region by an embodiment of a method of theinvention;

FIG. 13 is a diagram of an embodiment of a catheter of the inventionbeing used in an embodiment of a method of the invention;

FIGS. 14-15 depict an embodiment of a cutting device of the inventionbeing used in an embodiment of a method of the invention;

FIGS. 16-17 are elevations of an embodiment of a cutting device of theinvention with cutaways showing internal components;

FIGS. 18-20 depict an embodiment of a cutting device of the inventionbeing used in an embodiment of a method of the invention;

FIG. 21 is a perspective view of an embodiment of a cutting device ofthe invention;

FIG. 22 is an elevation of an embodiment of a cutting device of theinvention;

FIG. 23 is a bottom view of an embodiment of a cutting device of theinvention;

FIG. 24 is an end view showing lumens of an embodiment of a cuttingdevice of the invention;

FIG. 25 is an end view of an embodiment of a cutting device of theinvention;

FIGS. 26-28 are perspective views of an embodiment of a cutting deviceof the invention; and,

FIG. 29 is a perspective view of an embodiment of a cutting device ofthe invention.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

FIG. 1 illustrates in sagittal section, the female urogenital organs.Bladder B, urethra UR, vagina V, and uterus UT. FIG. 2 shows the bladderB in frontal-axial section (parallel to urethra), illustrating thetrigonal area or region T on the surface of the bladder, definedapproximately by the triangle of the ureteral ostia UO, and bladder neckBN. The bladder anatomy of the male is similar.

Afferent nerves emanate from various locations within the bladder, butafferent nerves that emanate from the trigonal region T (dashed line inFIG. 3), are believed to play a particularly important role inmodulating the urge to urinate. These afferent nerves travel from thebladder surface (mucosal layer) into the submucosal tissue andpotentially into the vaginal layer coextant with the bladder trigonaltissue. Disruption of some or all of these nerves is believed tointerfere with the pathological hyperactive voiding urge mechanism inpeople with over active bladder (OAB).

A first embodiment of a method of the invention shown in FIG. 4. Here, aballoon catheter 10 is placed in the submucosal tissue in the trigoneregion T. Upon inflation (using suitable inflation medium such as liquidor air), a dilated balloon 12 forms a dissection plane within thetissue, thus disrupting the afferent nerves therein. The balloon is thendeflated and removed, resulting in the dissection layer 14 shown in FIG.5. The balloon catheter 10 may be positioned in one or multiplelocations. FIG. 6 shows the resultant dissected regions 14 of multipleplacements and dilations. Multiple regions may be parallel, or “fannedout”, as shown. The dissected regions or planes 14 may overlap, or bediscontinuous (as shown). The size of the dissected plane(s) may beinfluenced by the balloon size, as well the number and position of theplacements. The dissected plane(s) may be completely within the trigoneregion T, or may extend beyond the trigone region T. One or moredissected planes 14 may also be outside the trigone region T. Thedissection plane(s) may be anywhere within the tissue of the bladdertrigone, or in the vaginal wall. The plane(s) may be just under themucosal layer, or at the junction of the vagina and bladder tissue.These layers may have a natural “separability” to facilitate relativelycontrolled dissectioning of the tissue.

The dissection plane(s) 14 may be stabilized following the dissectingprocedure by temporary placement of a Fogarty balloon in the bladder tokeep the dissected tissues in approximation. In this, as well as otherembodiments of the invention, other suitable devices may also be usedfrom either the bladder side and/or the vaginal side.

The dilation catheter 10 (which may also be an expandable mechanicaldilator), may be placed with the aid of various devices, as describedbelow. A representative visualization scope such as a cystoscope 20 isshown in FIGS. 7 and 8. This device 20 may include a channel 22 for anendoscope 24 (or could have built-in visualization), one or morechannels 26 for infusion/aspiration, and one or more channels (lumens)for delivery of “working devices” (working channel) 28.

The dilation catheter 10, seen in FIG. 9 (uninflated balloon 12) and 10(inflated balloon 12) may include a lumen for use with a guide wire 16.The guide wire lumen may extend the entire length of the ballooncatheter, as is shown in the figures, or may emerge alongside, somedistance from the tip, as is often the case with balloon catheters usedin vascular procedures (aka “monorail style”). This shorter wire lumenallows for easier installation of the balloon catheter over the proximalend of the guide wire after the guide wire has been placed at a desiredtarget location.

The guide wire 16 may be flexible and steerable, with a pre-formed curve18 at the distal end. The guide wire may be initially placedtransurethrally with the aid of the cystoscope 20, as shown in FIG. 11.Initially the cystoscope 20 is placed in the urethra to a site whereentry of the guide wire 16 is desired to be placed submucosally. Theguide wire may have a sharpened tip 19 to aid in penetrating the surfaceand advancing submucosally. A cautery device or other tissue penetratormay also be used to initially access the submucosal space. Imaging mayalso be used to facilitate navigation and placement, such as fluoroscopyor ultrasound.

Once the guide wire 16 is positioned, the cystoscope 20 may be removed,or may be left in place and the balloon catheter 10 advanced over theguide wire 16 and within the working channel 28. FIG. 12 shows thecystoscope 20 removed. FIG. 13 shows the balloon catheter 10 advancedover the guide wire to the target site for dilation. Positioning of theballoon 12 may be aided with markers (not shown) on the guide wire thatat a known distance from the tip, coupled with a known length of ballooncatheter, resulting in the tip of the balloon catheter being positioneda known distance from the guide wire. FIG. 4 shows the balloon in aninflated condition.

FIG. 5 is a side view showing the dissection plane 14 within the tissuebetween the bladder trigone region and the vagina. And, as mentionedabove, FIG. 6 shows the areas in an exemplary treatment with threedissection regions 14 following three balloon placements and inflations.

As with other embodiments of the invention, similar techniques could beperformed via a trans-vaginal approach, where the balloon catheter isplaced into the same region, but via the superior portion of the vagina.

FIGS. 14 and 15 illustrate an alternative embodiment of the invention.Here, a cutting device 30 is positioned in the submucosal space of thebladder trigone T. Cutting device 30 may be positioned in similarlocations as described above in connection with the balloon embodiments.

Cutting device 30 may be one of the cutting devices used in otherminimally invasive surgical procedures, such as those used throughworking channels of cyctoscopes for other urological or gynecologicalprocedures, or other scope devices used in other human minimallyinvasive surgical procedures. Such devices may be steerable and/ordeflectable. Furthermore they may also incorporate cautery or otherenergy combined with cutting to achieve cutting while minimizingbleeding.

The cutting device 30 may be positioned with the aid of a cystoscope 20,an exemplary version of which was illustrated in FIGS. 7 and 8, via aworking channel 28. Cutting device 30 may be further positioned with theaid of a guide wire 16, similar to that described in connection with theballoon catheter embodiments. The cutting device 30 may also be advancedin a tissue plane that has a natural “separability”, such as between thebladder mucosa and submucosa, or between the bladder trigone submucosaand the vaginal submucosa.

FIGS. 16 and 17 illustrate a novel and particularly useful embodiment ofa cutting device 30 for making submucosal dissection planes. Cuttingdevice 30 includes 2 laterally extendable blades 32, with cuttingsurfaces on their outer (lateral) aspects. When the cutting device isplaced in a target position, it is initially “closed”, as shown in FIG.16. Then the device is “opened”, by relative movement between theactivation tethers 34 and the body, creating a dissection plane widerthan the device. The activation tethers pull on the lever arms 38 of thecutting blades, and the cutting blades rotate outward about a pivot 40.The cutting device may be further advanced to make a more elongatedissection plane. The cutting device may be repositioned to makemultiple laterally displaced cutting planes 14, as shown in FIG. 6. Suchdissection planes 14 may ultimately be conjoined to form one relativelylarge dissection plane in the submucosal region of the bladder trigone.

FIGS. 18-19 show another embodiment 50 of a cutting device. Here, theblades 52 may be relatively long, and as such may create a largerdissection plane 14 in the submucosal surface when the blades are openedlaterally, as shown in FIGS. 18-20.

As with the balloon embodiments, these cutting device embodiments mayalso be used from the vaginal side of the bladder trigone to create oneor more submucosal dissection planes.

FIGS. 21-25 illustrate yet another alternative embodiment 60 for acutting tool. Here cutting tool 60 may include a positioning guide 62.Positioning guide 62 may include a suction paddle 64 for engagement withthe bladder mucosa, and a cutting blade 66 (shown retracted) within acutting blade lumen 68, and a visualization device 70 such as anendoscope.

In operation, the positioning guide 62 is placed into the bladdertransurethrally to a site of interest, such as adjacent the trigoneregion. If a dissection plane is to be made, the suction paddle 64 isplaced against the bladder mucosa in the region to be submucosallydissected. Note that the endoscope 70 may be movable longitudinallywithin the scope channel 72 to help with precise placement of the distaltip of the suction paddle 64, as seen in FIG. 26. Advancing theendoscope 70 to near the tip can be particularly advantageous toaccurately position the tip relative to the ureteral orifices in orderto avoid damage to them.

Once in a desired location, the suction paddle 64 is activated byapplying suction to the suction lumen 74 (FIGS. 24). Valves (not shown)operative with the lumen 74 may be incorporated. Apertures 76 in thetissue face of the suction paddle 64 then securely engage the mucosaltissue. The blade is then advanced, as seen in FIG. 28.

Because the cutting blade lumen is parallel to but offset from thetissue face, as shown in FIG. P3, the cutting blade cuts a dissectionplane at a predetermined depth submucosally. A handle mechanism (notshown) may be incorporated to manage and control the positions of theproximal ends of the cutting blade and/or the endoscope.

The positioning guide 62 can be placed in multiple locations byrepeatedly removing suction, manipulating the guide, re-applyingsuction, and re-advancing the blade. In this manner, multiple submucosaldissection planes can be generated in the bladder trigone area.

As with other embodiments above, the cutting blade 66 may incorporatecautery, such as monopolar RF applied to the blade, or bipolar RF energyapplied from the blade to the suction head. In such a case, portions ofthe cutting blade and suction head are appropriately conductive, andadjoining surfaces are appropriately electrically insulated.

Also, as with other embodiments above, the positioning guide embodimentsmay be utilized via a trans-vaginal approach.

In yet a further embodiment, the positioning guide 62 described above,with the suction paddle 64, may be used with other cutting mechanismsthat are placed submucosally via the cutting channel. An appropriatelysized cutting channel is incorporated, depending on the size and shapeof the cutting device to be used.

For example, FIG. 29 shows the cutting device 60 employing atranslatable cutting mechanism 80. In addition to being able to beadvanced and retracted longitudinally, as shown by arrow 82, the cuttingmechanism 80 as able to be translated from side to side as shown inarrow 84. In order to maximize translation, a pivot point (not shown) islocated as near the distal opening of the lumen 68 when the mechanism 80is advanced longitudinally to its distal extent. The sides of the lumen68 may act as translation limits. In this way, the desired degree oftranslation may be controlled by the amount the mechanism 80 is advanceddistally. Retracting the mechanism 80 proximally reduces the degree towhich the mechanism 80 may be translated side-to-side.

It is understood that mechanism 80 may comprise a blade or needle andmay be energized for ablation, to form a lesion, or cauterization. If aneedle is used as the mechanism 80, the translation feature is usedprior to advancing the needle out of the lumen 68, and is thus used tocontrol the angular direction the needle travels out of the lumen. Inthis way, several injection lines may be effected without repositioningthe positioning guide 62.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof. For example, one alternative to the methods of theinvention may include trans-urethral trigonal resection—whether bymechanical or energy delivery (including cryo) means. Resection mayinvolve removal or destruction of a layer of desired thickness (rangingfrom the 1 mm mucosal thickness to the 5-6 mm complete bladder wallthickness) which would include nerves and nerve endings involved in OAB.As an additional example, the devices described above may be modified(e.g. by making longer and/or flexible) for use in the male anatomy.

1-3. (canceled)
 4. A method of creating at least one dissection plane within a wall of a bladder trigone comprising: placing a balloon in the bladder trigone via a urethra; and, inflating said balloon to form a dissection plane within the bladder wall.
 5. The method of claim 4 further comprising advancing a guide wire within the bladder wall, and then advancing the balloon along the guide wire.
 6. The method of claim 4 wherein placing a balloon in the bladder trigone via a urethra comprises advancing a guide wire within the bladder wall and then advancing the balloon along the guide wire.
 7. The method of claim 4 further comprising the steps of: deflating the balloon; relocating the balloon to at least a second location; and, reinflating the balloon.
 8. A method of creating at least one dissection plane within the wall of a bladder trigone comprising: placing a cutting tool at a bladder trigone via a urethra, said cutting tool including a suction paddle and a blade spaced apart from and generally parallel to a surface of said suction paddle; applying suction to said suction paddle to engage tissue of the bladder trigone; and, forming a dissection plane within the wall by advancing said blade through said engaged tissue.
 9. The method of claim 8 wherein the cutting tool has a generally longitudinal axis, and the blade is advanced generally parallel to the longitudinal axis.
 10. The method of claim 8 wherein advancing said blade through said engaged tissue comprises advancing said blade in a direction generally parallel to a longitudinal axis of the cutting tool.
 11. The method of claim 8 wherein the cutting tool has a generally longitudinal axis, and the blade is advanced in a direction having a lateral component relative to the longitudinal axis.
 12. The method of claim 8 further comprising repositioning of the cutting tool to a different position on the bladder trigone and either: forming an additional dissection plane, or extending the previous dissection plane.
 13. The method of claim 8 wherein the cutting tool includes an endoscope. 14-19. (canceled)
 20. A method of treating over active bladder comprising: advancing a device through the urethra and into tissue below a surface of a trigone region of a bladder such that a portion of the device is configured to extends into tissue between the bladder surface and a vaginal surface; creating a dissection plane with the device to disrupt nerves associated with over active bladder.
 21. The method of claim 20 wherein advancing a device comprises advancing a device that includes a dilation balloon.
 22. The method of claim 20 wherein advancing a device comprises advancing a device that includes a cutting blade.
 23. The method of claim 20 wherein advancing a device comprises advancing a device that includes a positioning guide configured to engage tissue at the surface of the bladder.
 24. (canceled) 